Oral Glutamine and Mucositis of Head and Neck Cancer Patients Undergoing Radiation

November 2, 2015 updated by: Shih-An Liu, Taichung Veterans General Hospital

The Influence of Glutamine on the Side Effects of Chemo-radiation in Head and Neck Cancer Patients - A Randomized Controlled Trial

This study will enroll 60 consecutive patients who are scheduled to receive radiotherapy with/without chemotherapy due to head and neck cancers. Basic data will be recorded along with tumor related variables. Then they will be divided randomly into study group and control group. The study group will receive oral glutamine during radiotherapy while the control group will receive placebo during radiotherapy. The severity of oral mucositis (WHO grading system), pain status (visual analogue scale), quality of life questionnaires will also be documented. The differences between the two groups will be analyzed.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Chemotherapy and radiotherapy are important therapeutic modalities for head and neck cancer patients. Oral mucositis is a common comorbidity during chemotherapy and radiotherapy. It was reported that 30-60% of patients underwent chemotherapy and over 90% of patients receiving radiotherapy had oral mucositis. Oral mucositis not only reduces the quality of life of cancer patients during therapy but also causes dysphagia and poor nutritional status. Severe oral mucositis may necessitate unplanned gaps between treatment which can undermine the chance of local control.

In terms of management of oral mucositis, maintaining of oral hygiene and avoid infection are essential manner. Topical agents such as sucralfate, benzydamine, antifungal drugs, vitamin E and treatment using laser were studied in the management of oral mucositis. Previous studies indicated the glutamine significantly reduced the incidence and severity of oral mucositis in patients underwent chemotherapy and bone marrow transplantation. However, few studies discussed the effect of glutamine on the impact of oral mucositis in head and neck cancer patients receiving radiotherapy with/without chemotherapy.

This study will enroll 60 consecutive patients who are scheduled to receive radiotherapy with/without chemotherapy due to head and neck cancers. Basic data will be recorded along with tumor related variables. Then they will be divided randomly into study group and control group. The study group will receive oral glutamine while the control group will receive placebo during radiotherapy. The severity of oral mucositis (WHO grading system, every week), pain status (visual analogue scale, every week), quality of life questionnaires (before, during and after radiotherapy) will also be documented. The differences between the two groups will be analyzed.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taichung, Taiwan, 40705
        • Recruiting
        • Department of Otolaryngology Head Neck Surgery, Taichung Veterans General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Head and neck cancer patients scheduled to receive radiotherapy with or without chemotherapy

Exclusion Criteria:

  • Prior radiotherapy to the head and neck region
  • Severe liver or renal disease
  • Reye's syndrome
  • Allergy to glutamine
  • Reluctant to join the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Study group
Oral glutamine 10 g TID (total 30 g/day) one week before radiotherapy till the end of radiotherapy
Dietary supplement: Glutamine
Powder that soluble in water for drinking, 10g TID (total 30 g per day)
Other Names:
  • AMINOPURE (Ajinomoto AmoniScience LLC)
Placebo Comparator: Control group
Placebo (Same ingredients without glutamine) one week before radiotherapy till the end of radiotherapy
Dietary supplement: Placebo
Powder that provided by manufacturer with the same ingredients yet without glutamine, TID use

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oral mucositis
Time Frame: 8 weeks
According to WHO grading system
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain status
Time Frame: 8 weeks
Pain status by visual analog scale
8 weeks
Quality of life
Time Frame: 8 weeks
Washington University Quality of life questionaire
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taichung Veterans General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

October 31, 2014

First Submitted That Met QC Criteria

November 3, 2014

First Posted (Estimate)

November 4, 2014

Study Record Updates

Last Update Posted (Estimate)

November 4, 2015

Last Update Submitted That Met QC Criteria

November 2, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TCVGH-1047004C

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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